Events

SynchroMed® II Pump 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Medtronic 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2012-03-20
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120321a.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Field safety notice: medtronic synchromed® ii pump the medicines and healthcare products regulatory agencies (mhra), united kingdom posted a field safety notice concerning the synchromed® ii pump, manufactured by medtronics inc. the notice provided important information regarding the “schedule to replace the pump by” date displayed on the model 8840 n’vision® physician programmer and printed reports, for the model 8637 synchromedr ii implantable drug infusion pump. in some circumstances after a pump’s elective replacement indicator (eri) has occurred, the “schedule to replace the pump by” date may be incorrectly displayed as a series of question marks (??/??/????), or as a date greater than 90 days from the eri date, potentially leading to the pump reaching end of service (eos) prior to replacement. medtronic has confirmed that an algorithm used in the model 8870 application card software has resulted in nine occurrences of an incorrectly displayed “schedule to replace the pump by” date. it is estimated that there are more than 140,000 synchromed ii pump implants worldwide. a patient with a pump reaching eos prior to replacement may experience the return of underlying symptoms and/or withdrawal symptoms. intrathecal baclofen patients could experience baclofen withdrawal syndrome, which can be life threatening. no adverse events have been reported for eight of the confirmed cases, and one intrathecal baclofen therapy (itb) patient experienced decreased therapeutic effect with increased spasticity due to the pump reaching eos prior to replacement. the manufacturer advised customers to take the following actions: continue normal follow up schedule, and monitor the estimated number of months until eri. follow labelled recommendations for pump replacement within 90 days* of eri declaration. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the product, please contact your supplier for necessary actions.

Device

SynchroMed® II Pump
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Medtronic SynchroMed® II Pump
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH